Lilly To Discontinue Phase 3 Development Program For OLUMIANT In Lupus - Quick Facts

(RTTNews) - Eli Lilly and Company (LLY) said, based on top-line efficacy results from two pivotal phase 3 trials (SLE-BRAVE-I and II), the company has decided to discontinue the phase 3 development program for OLUMIANT in lupus. The company is working with investigators to appropriately conclude the phase 3 SLE long-term extension trial, SLE-BRAVE-X.

Lilly noted that it is in ongoing discussion with the FDA regarding the status of the sNDA for OLUMIANT for the treatment of adults with moderate-to-severe atopic dermatitis. Given the Agency's position, there is a possibility that this could lead to a Complete Response Letter, the company said.

"We look forward to potential regulatory approvals for OLUMIANT in 2022, including COVID-19 for certain hospitalized patients in the U.S. and severe alopecia areata in the U.S., European Union and Japan, where OLUMIANT has the potential to be a first-in-disease treatment," said Lotus Mallbris, vice president of global immunology development and medical affairs at Lilly.